News

20.09.2021

Remote audits of global manufacturers of medical devices

Journal “Laboratory” No. 08/2020 The text of the article is available only in Ukrainian

Read more
06.09.2021

Certification of medical device manufacturing by pharmaceutical companies

PROGRAM Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies: medical devices supplied with a medicinal product medical devices for drug delivery products that are integral with the medicinal product products for IVD, RUO (research use only) and general laboratory equipment medical / cosmetic / hygienic purpose of products aids (accessories) Requirements of […]

Read more
26.08.2021

Regulatory requirements for medical devices in laboratory practice

PROGRAM Classification: medical device for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration Conformity assessment performed by conformity assessment body: choosing the best procedure for your business application and documentation step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities special procedure for III class devices, […]

Read more
26.08.2021

Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices

PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]

Read more
21.05.2021

The 10th anniversary Ukrainian forum of medical device market operators was held

On May 14, the 10th anniversary Ukrainian forum of medical device market operators took place, which traditionally provides manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience. Ukrainian Scientific Institute of Certification was a partner of this event. In addition, Anna Telpiakova, First Deputy Director of […]

Read more
17.05.2021

UNI-CERT extended the field of activity of its Testing Laboratory

Once again, the Ukrainian Scientific Institute of Certification has extended the accreditation scope of its Testing Laboratory UNI-CERT LLC, and this time by 23 standards and 127 test indicators in the field of Personal Protective Equipment (PPE). According to the accreditation certificate No. 201394 and number of additions to the accreditation scope, the Testing Laboratory […]

Read more